OSAKA, JapanIrinotecan/cisplatin combination therapy improved
survival compared to etoposide/cisplatin in extensive-stage
small-cell lung cancer (SCLC), Masahiro Fukuoka, MD, reported at an
investigators workshop sponsored by the University of Texas M.
D. Anderson Cancer Center and Pharmacia Oncology. Two-year survival
in the Japan Clinical Oncology Group (JCOG)-9511 study was 19% with
irinotecan/cisplatin vs 9% with etoposide/cisplatin, according to Dr.
Fukuoka, who is professor of the 4th Department of Internal Medicine
at Kinki University School of Medicine in Osaka, Japan.

To lay the groundwork for JCOG-9511, Dr. Fukuoka first reviewed data
from a phase II study of irinotecan (Camptosar) and etoposide
(VePesid) in 50 patients with extensive-stage SCLC. The
combination of irinotecan and etoposide yielded an overall response
rate of 66%, with a complete response rate of 10% in patients with
previously untreated extensive-disease SCLC, Dr. Fukuoka said.
Median survival time was 11.5 months. One-year survival was
43.2%, and 2-year survival was 21.3%. Toxicity was mild, with 28.0%
grade 3 or 4 leukopenia and 62.9% grade 3 or 4 neutropenia. Only one
patient experienced grade 3 diarrhea, and there was no
treatment-related mortality. Other major toxicities were
leukopenia in 28% and anemia in 14%. This
topoisomerase-targeting chemotherapy is a new, active regimen for
extensive-disease SCLC, Dr. Fukuoka stated.

Phase III Study Results

These
promising data led to the phase III JCOG-9511 study, which compared
irinotecan/cisplatin (Platinol) to etoposide/cisplatin in 154
patients with extensive, previously untreated SCLC. Dr. Fukuoka
reported that at the first planned interim analysis, the overall
response rate was significantly better with irinotecan/cisplatin
(83.1%) than with etoposide/cisplatin (67.5%), and accrual stopped
because of better survival. As of the March 2000, follow-up analysis,
the survival advantage with irinotecan/cisplatin had been sustained
(see Table), and 2-year survival was 19% with irinotecan/cisplatin vs
9% with etoposide/cisplatin (P = .0021). This had led to
irinotecan/cisplatin becoming the new standard of care in Japan for
extensive disease SCLC.

Neutropenia was a major problem on both regimens and thrombocytopenia
was relatively rare in either. Otherwise, the two regimens have
somewhat different toxicity profiles. Leukopenia was more common with
irinotecan/cisplatin. Dr. Fukuoka said that diarrhea was the most
problematic nonhematologic side effect with that regimen. There were
four treatment-related deathsthree in the irinotecan/cisplatin
arm, and one in the etoposide/cisplatin arm.

This regimen is very active in SCLC. Major toxicities are
neutropenia and diarrhea, but irinotecan/cisplatin produces better
survival than etoposide/cisplatin in extensive SCLC, Dr.
Fukuoka concluded.

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